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Trial record 69 of 470 for:    TRAMADOL

Role of Prophylactic Metoclopramide With Tramadol in Trauma Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03383315
Recruitment Status : Completed
First Posted : December 26, 2017
Last Update Posted : December 26, 2017
Sponsor:
Information provided by (Responsible Party):
Dr Choo Kim Hoon, University of Malaya

Tracking Information
First Submitted Date  ICMJE December 18, 2017
First Posted Date  ICMJE December 26, 2017
Last Update Posted Date December 26, 2017
Actual Study Start Date  ICMJE July 1, 2017
Actual Primary Completion Date September 30, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 22, 2017)
Nausea severity scale [ Time Frame: One hour ]
Change in rating of nausea severity on Visual Analogue Scale 60 minutes after administration of the study drugs. VAS is a standard 100mm line marked "no nausea" at the left end and "worst nausea imaginable" at the right end. Minimum clinically significant difference is defined for this study as 20 mm increment.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: December 22, 2017)
Vomiting [ Time Frame: One hour ]
Number of episodes of vomiting 60 minutes after administration of study drugs
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Role of Prophylactic Metoclopramide With Tramadol in Trauma Patients
Official Title  ICMJE Role of Prophylactic Metoclopramide With Tramadol in Trauma Patients: A Randomised, Double Blind Placebo Controlled Trial
Brief Summary Tramadol is widely used as analgesic in trauma patients. However, it causes side effects, most notably nausea and vomiting. This study aim to determine the role of prophylactic metoclopramide in preventing tramadol induced nausea and vomiting.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Patients are randomized into two groups. One group receives tramadol and metoclopramide, while another group receives tramadol and placebo (normal saline).
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description:
The study drugs were prepared under sterile conditions by a pharmacist independent to the study and kept in packs.The patients recruited were randomized to receive one of the study packs. The study pack were numbered by the pharmacist, who used a computer-generated random number sequence to assign treatment allocations. The allocation list was kept by the pharmacist. Treatment allocations were revealed only after study completion, when all outcome measurements had been performed and recorded by the investigator in the study database.
Primary Purpose: Prevention
Condition  ICMJE
  • Trauma
  • Opioid Analgesic Adverse Reaction
Intervention  ICMJE
  • Drug: Tramadol
    One dose of intravenous tramadol 50mg
  • Drug: Metoclopramide
    One dose of intravenous metoclopramide 10mg
  • Drug: Placebo
    Sodium chloride 0.9%
Study Arms  ICMJE
  • Experimental: Group 1
    Intravenous tramadol 50mg + intravenous metoclopramide 10mg
    Interventions:
    • Drug: Tramadol
    • Drug: Metoclopramide
  • Active Comparator: Group 2
    Intravenous tramadol 50mg + placebo (normal saline)
    Interventions:
    • Drug: Tramadol
    • Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 22, 2017)
191
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 30, 2017
Actual Primary Completion Date September 30, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients aged 18 years or older on day of presentation to ETD SGH
  • Sustained from traumatic injuries of extremities (Fracture of hand & wrist, radius, ulna, humerus, femur, tibia, fibula and/or foot & ankle; laceration wounds of extremities; soft tissue injury)
  • Patient who is able to give consent

Exclusion Criteria:

  • Known allergy to metoclopramide
  • Concurrently taking medication with anti-emetic effect, including antihistamines, phenothiazines and dopamine antagonists.
  • A history of vomiting since time of injury
  • Patients who had already received tramadol or metoclopramide in the previous 8 hours prior to arrival at ETD
  • Below age of 18 on day of presentation, or patients who could not consent to the study
  • Any alteration in level of consciousness
  • Hemodynamic instability or primary diagnosis requiring time critical intervention
  • Pregnancy or lactation
  • History or known case of vertiginous disorder
  • Currently undergoing chemotherapy or radiotherapy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Malaysia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03383315
Other Study ID Numbers  ICMJE NMRR-16-1688-32638
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Dr Choo Kim Hoon, University of Malaya
Study Sponsor  ICMJE University of Malaya
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Malaya
Verification Date December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP